Test Catalog

Test Id : CARTF

Carbamazepine Profile, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring patients exhibiting symptoms of carbamazepine toxicity whose total serum carbamazepine concentration is within the therapeutic range, but who may be producing significant levels of the active metabolite epoxide

 

Free carbamazepine concentration may also be useful to monitor in patients with altered or unpredictable protein binding capacity

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
CARTA Carbamazepine, Tot, S Yes Yes
1011E Carb-10,11-Epoxide, S No Yes
CARF Carbamazepine, Free, S Yes Yes

Method Name
A short description of the method used to perform the test

CARTA: Homogeneous Microparticle Agglutination Immunoassay

1011E: High-Performance Liquid Chromatography (HPLC)

CARF: Ultrafiltration Followed by Homogeneous Microparticle Agglutination Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Carbamazepine Profile, S

Aliases
Lists additional common names for a test, as an aid in searching

Carbamazepine (Carbatrol, Tegretol)

Carbamazepine Metabolite

Carbatrol (Carbamazepine)

Epoxide 10,11

Free and Total Carbamazepine

Tegretol (Carbamazepine)

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Red top

Specimen Volume: 2 mL

Collection Instructions:

1. Draw blood 12 hours (trough value) after last dose.

2. Tubes should be centrifuged and aliquoted within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 7 days
Frozen 28 days
Ambient 48 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring patients exhibiting symptoms of carbamazepine toxicity whose total serum carbamazepine concentration is within the therapeutic range, but who may be producing significant levels of the active metabolite epoxide

 

Free carbamazepine concentration may also be useful to monitor in patients with altered or unpredictable protein binding capacity

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Carbamazepine is a common antiepileptic drug. It is a first-line drug for treatment of partial seizures and trigeminal neuralgia.

 

Carbamazepine is metabolized by the liver to carbamazepine-10,11-epoxide (CBZ10-11), which is pharmacologically active and potentially toxic. CBZ10-11 is, in turn, inactivated by hepatic conversion to a transdiol derivative.

 

CBZ10-11 may be responsible for the congenital abnormalities that are sometimes associated with the use of carbamazepine during early pregnancy. There have been cases of severe seizures exacerbation when serum epoxide levels were increased. Toxic levels of CBZ10-11 can occur during:

-Concomitant administration of other drugs that induce hepatic oxidizing enzymes (eg, most antiepileptic drugs [with the exception of valproic acid and the benzodiazepines], propoxyphene)

-Concomitant administration of drugs that inhibit its breakdown such as valproic acid, felbamate, and lamotrigine

-High-dose carbamazepine therapy, especially in combination with the above conditions

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

CARBAMAZEPINE, TOTAL

Therapeutic: 4.0-12.0 mcg/mL

Critical value: > or =15.0 mcg/mL

 

CARBAMAZEPINE-10,11-EPOXIDE

Therapeutic: 0.4-4.0 mcg/mL

Toxic concentration: > or =8.0 mcg/mL

 

CARBAMAZEPINE, FREE

Therapeutic: 1.0-3.0 mcg/mL

Critical value: > or =4.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

The clinically acceptable serum concentration of carbamazepine-10,11-epoxide (CBZ10-11) is not well established, but 4.0 mcg/mL has often been used as an upper limit for its therapeutic range.

 

The ratio of CBZ10-11 to carbamazepine is usually less than or equal to 0.2 mcg/mL in symptomatic adults and less than or equal to 0.3 mcg/mL in children.

 

Clinical correlation is aided by comparing values obtained when the patient is symptomatic with those obtained when the patient has improved.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Routine determination of carbamazepine-10,11-epoxide (CBZ10-11) is not clinically indicated. It should be considered when the source of treatment in associated symptoms is not obvious.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Theodore WH, Narang PK, Holmes MD, et al: Carbamazepine and its epoxide: relation of plasma levels to toxicity and seizure control. Ann Neurol 1989;25:194-196

2. Tomson T, Almkvist O, Nilsson BY, et al: Carbamazepine-10, 11-epoxide in epilepsy. A pilot study. Arch Neurol 1990;47:888-892

3. McKauge L, Tyrer JH, Eadie MI: Factors influencing simultaneous concentrations of carbamazepine and its epoxide in plasma. Ther Drug Monit 1981;3:63-70

4. Brodie MJ, Forrest G, Rapeport WG: Carbamazepine-10,11-epoxide concentrations in epileptics of carbamazepine alone and in combination with other anticonvulsants. Br J Clin Pharmacol 1983;16:747-749

5. Shoeman JF, Elyas AA, Brett EM, Lascelles PT: Correlation between plasma carbamazepine-10,11-epoxide concentration and drug side-effects in children with epilepsy. Dev Med Child Neurol 1984;26:756-764

Method Description
Describes how the test is performed and provides a method-specific reference

Carbamazepine, Total:

CARTA: The ONLINE TDM Carbamazepine Gen.4 assay is a homogeneous microparticle agglutination immunoassay. It is a 2-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using automated analyzers. In this technology biotinylated drug hapten attached to streptavidin coated latex beads serves as the binding partner to anticarbamazepine antibody. A competitive reaction to a limited amount of specific anticarbamazepine antibody takes place between the latex bound hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.(Package insert: Roche Carbamazepine reagent, Roche Diagnostic Corp, Indianapolis, IN)

 

Carbamazepine, Free:

Free carbamazepine is isolated from serum by ultrafiltration.

CARTA: The ONLINE TDM Carbamazepine Gen.4 assay is a homogeneous microparticle agglutination immunoassay. It is a 2-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using automated analyzers. In this technology biotinylated drug hapten attached to streptavidin coated latex beads serves as the binding partner to anti-carbamazepine antibody. A competitive reaction to a limited amount of specific anti-carbamazepine antibody takes place between the latex bound hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.(Package insert: Roche Carbamazepine reagent, Roche Diagnostic Corp, Indianapolis, IN)

 

Carbamazepine-10,11-Epoxide:

High-performance liquid chromatography (HPLC).(Chelberg RD, Gunawan S, Treiman DM: Simultaneous high-performance liquid chromatography determination of carbamazepine and its principal metabolites in human plasma and urine. Ther Drug Monit 1988;10:188-193)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

CARTA, CARF: Monday through Sunday

1011E: Tuesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

CARTA: 1 week; CARF: 1 week; 1011E: 2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80156-Carbamazepine, total

80157-Carbamazepine, free

80161-Carbamazepine-10,11-Epoxide

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CARTF Carbamazepine Profile, S 50337-5
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
7467 Carb-10,11-Epoxide, S 9415-1
CARTA Carbamazepine, Tot, S 3432-2
CARF Carbamazepine, Free, S 3433-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports